ST elevated myocard infarct
Conditions
Interventions
All eligible patients will receive ASA as per standard of care and
P2Y12-loading dose followed by 30-45 days DAPT (ASA + Prasugrel)
Enrolment will be performed in all STEMI patients undergoing PCI.
Sponsors
Research Maatschap Cardiologen Rotterdam Zuid
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria at index procedure All STEMI patients who are planned to be treated with PCI: ST segment elevation myocardial infarction: Chest discomfort suggestive of cardiac ischemia >=20 min at rest with 1 of the following ECG features: • ST segment elevation >=2 contiguous ECG leads • new or presumably new left bundle branch block Inclusion Criteria at 30-45 days • All patients who have provided informed consent • Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0) • No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater). • Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of
Exclusion criteria
Exclusion criteria: - Patients on oral anticoagulation - Contraindication to P2Y12 inhibitors and/or to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg/week or more). - Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2). - Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin) - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital - Platelet count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first primary objective of this Open-label, Randomized, Controlled Clinical Trial is to demonstrate the non inferority of a Prasugrel-based short DAPT (30-45 days) followed by 11-month Prasugrel monotherapy versus standard DAPT regimen by assessing: - Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of death, MI, stroke or BARC bleeding 3 or 5 The co-primary objective is to demonstrate in patients with multivessel disease the superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion by assessing: - Post-procedural Minimal Stent Area (MSA) | — |
Secondary
| Measure | Time frame |
|---|---|
| With respect to the antithrombotic therapy analysis, the secondary exploratory objectives primarily include the assessment of the primary endpoint for superiority if non-inferiority is demonstrated and the assessment of differences between the two antithrombotic regimens compared in the trial for the following endpoints (key secondary endpoints): • Composite of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke • BARC type 3 or 5 events - Incidence of stent thrombosis (definite or probable as defined by the Academic Research Consortium) With respect to the imaging-based analysis, the secondary exploratory objectives include the assessment of differences between OCT- and angiography-guided revascularization completion in terms of 12-month target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization. In the subgroup of patients with multivessel disease, the interaction between antithrombotic therapy regimens (i.e. short DAPT followed by Prasugrel monotherapy versus standard DAPT) and the type of guidance to achieve revascularization completeness (i.e., OCT- versus angiography-guided) for the primary and key secondary endpoints will be formally explored by Cox proportional hazards regression models including the two factors as covariates alongside their interaction term. | — |
Countries
Belgium, Czech Republic, Germany, Italy, Netherlands, Serbia
Contacts
Public ContactM.A. Vliet
Research Maatschap Cardiologen Rotterdam Zuid
Outcome results
None listed